Phase II study of S-1 monotherapy as 1st line chemotherapy in patients > or = 80 with advanced non-small cell lung cancer

Phase 2

Recruiting

• Conditions: patients > or = 80 with advanced non-small cell lung cancer

• Registration Number: JPRN-UMIN000008490
• Lead Sponsor: Shinshu University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-01
• Study Completion: 2016-04-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

1) History of severe hypersensitivity drug reaction 2) Prior radiotherapy to the primary tumor except the radiotherapy to the bone metastasis and the brain metastasis. 3) Patients with administration contraindication to S-1 4) Synchronous cancer, or metachronous cancer with less than 5 years of disease-free interval except carcinoma in situ of the cervix and basal type skin cancer 5) Concomitant active infection 6) Radiographically confirmed interstitial pneumonitis or pulmonary fibrosis 7) Severe complication(s), e.g., renal failure, hepatic failure, poorly controlled diabetes, or poorly controlled hypertension 8) Distinctly abnormal ECG or cardiovascular disease (heart failure, myocardial infarction, angina) 9) Patients with severe diarrhea 10) Pleural and peritoneal likely to require surgical intervention 11) Symptomatic brain metastasis. 12) Concomitant treatment with flucytosine, phenytoin or warfarin 13) Physician concludes that the patient's participation in this trial is inappropriate

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-control rate

Secondary Outcome Measures

Name	Time	Method
Overall survival Progression free survival 1 year survival rate Response rate Time to treatment failure Safety Quality of life